Abbott recalls its Amplatzer Steerable Delivery Sheath due to an increased risk for air bubbles to be introduced into patients undergoing procedures.
Defender Pharmaceuticals files an NDA for its intranasally administered scopolamine gel for preventing motion-caused nausea and vomiting in adults.
An FDA update clarifies the intended use of radiological computer-aided triage and notification devices for intracranial large vessel occlusion.
FDA clears a Beckman Coulter 510(k) for its DxC 500 AU Chemistry Analyzer, an automated analyzer intended for use by small-to-medium-sized labs.
FDA says that a reverse-FOIA lawsuit seeking to shield an unnamed company attorneys identity in connection with a Form FDA-483 should be dismissed.
The 3rd Circuit Court of Appeals agrees with a Pennsylvania federal court that FDA failed to state the offense under the law in charging generic drug ...
FDA warns Stratus Biosystems that it is illegally marketing biological products whose manufacturing has significant deviations from CGMP requirements.
FDA says the Teva and Apotex generic forms of Vandas Hetlioz do not violate labeling requirements or raise safety concerns due to some different eleme...
